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FDA is Getting Ready for Its Close-up on Labels

Through a series of recent statements, FDA Commissioner Scott Gottlieb has signaled that the agency is prepared to assert its enforcement authority in reviewing label claims and modernizing standards of identity for certain products.

These developments are linked to the FDA Nutrition Innovation Strategy announced earlier this year by Gottlieb which is intended to examine ways to reduce preventable death and disease related to poor nutrition.

Combatting Organic Fraud

Earlier this month, Gottlieb announced that he soon intends to release more detailed information on what different terms mean on food packaging in order to help consumers best use claims such as organic and antibiotic-free. In a series of tweets, he explained that the FDA and USDA have distinct roles as it relates to the oversight of organic foods. While USDA regulates the use of the term “organic” on food labels, Gottlieb noted that the FDA oversees general food labeling compliance and safety issues.

Gottlieb acknowledged that his announcement was in response to an opinion piece in the Wall Street Journal by Dr. Henry Miller, the founding director of the FDA’s Office of Biotechnology, which contended that the FDA overlooks transgressions by the organic industry while they promote false and deceptive advertising claims. In the piece, Dr. Miller argued that organic farmers rely on synthetic and natural pesticides to grow their crops, just as conventional farmers do, and “organic products can contain numerous synthetic as well as natural chemicals.”

In concluding his series of tweets on the subject, Gottlieb stated that the FDA is focused on empowering consumers with tools and information to make good food choices consistent with public health recommendations, and encourage development of healthier foods by the industry. “This also means making sure terms on labels are actionable,” he declared.

“An Almond Doesn’t Lactate”

Over the next year, the FDA will be examining how the agency next steps on modernizing the agency’s standards of identity which will include issuing a guidance document for industry and a new compliance policy outlining the FDA’s enforcement approach. Gottlieb revealed these plans in a policy summit last month sponsored by Politico.

Gottlieb acknowledged that one area in need of clarity is the wide variety of plant-based foods that are positioned in the marketplace as substitutes for standardized dairy products, including a proliferation of soy, almond, or rice products calling themselves milk. However, he added that these alternative products are not the food that has been standardized under the name “milk” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

“An almond doesn’t lactate, I will confess,” Gottlieb quipped during the summit.

What Happens Next

It certainly is notable for the FDA Commissioner to signal that the agency intends to take measures to combat organic fraud. As Arent Fox has written before, there has been increased scrutiny of the organic label, especially through media investigations, so it was a matter of time before the issue received some regulatory focus.

However, there likely will not be any immediate enforcement activity from the FDA on organic labeling anytime soon. While the release of more detailed information on what different terms mean is forthcoming from the FDA, it is not clear whether this information will include enforcement plans.

The same situation applies to standards of identity, and Gottlieb acknowledged this during the Politico summit. After explaining that the FDA would first gather public comments before acting on next steps in standards of identity for milk, Gottlieb stated, “This is going to take time. It’s not going to take two years, but it probably takes something close to a year” to go through that process.

Between these statements, and the FDA’s recent assertions that it should have jurisdiction over cell-cultured meat products, Gottlieb continues to demonstrate a proclivity to counter the anti-regulatory narrative that the current administration attempts to convey.

Compare jurisdictions:Life Sciences: Product Regulation and Liability

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